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Beckman Coulter AU System — recall 63189

Health Canada — Medical Devices · Canada · 2020-02-28 · Type III

As described by Health Canada — Medical Devices: Beckman Coulter AU System - Liquid Urine Chemistry Calibrator (2020-02-05)

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
63189
Date of alert
2020-02-28
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Liquid Urine Chemistry Calibrator (lot 1809005B) may contain precipitate which when used with uric acid reagent ref OSR6X98 (OSR6098, OSR6198, OSR6298, AND OSR6698), may lead to incorrect calibration and QC failures.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/beckman-coulter-au-system-liqu

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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